NCT02219750

Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients

Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes

Detailed description

This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a 1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period. All study procedure will be conducted after obtaining informed consent.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	switch twice-daily insulin	compare two different insuiln regimen in basal insuln base and premixed insulin. NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2014-08-19
• Last updated: 2018-08-17

Locations

1 site across 1 country: Taiwan